RosaceaPhase 2NCT01359228
Rifaximin Treatment of Papulopustular Rosacea
A Phase 2 study testing Rifaximin (XIFAXAN) in people with Rosacea, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of rifaximin on skin symptoms in patients with rosacea by double-blinded, placebo-controlled, crossover study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- Rifaximin (XIFAXAN)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females
- > 18 years of age with rosacea defined as:
- 3-40 papules/pustules and < 2 nodules,
- A score of 2-4 on the Investigator Global Assessment
Who cannot join
- Untreated pancreatic insufficiency
- Crohn's disease
- Ulcerative colitis
- Active celiac disease by clinical history
- End stage renal failure
- Less than 18 years old
Show all 12Show fewer
- Pregnancy or positive pregnancy test
- Rosacea subtype 1 (no papules )
- Topical or oral antibiotics within 4 weeks
- Acne treatments within 4 weeks prior to randomization
- Systemic retinoids within 90 days
- Topical or systemic corticosteroids 4 weeks prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF, CTSI, 12-Moffitt/Long Hospital
San Francisco, California, 94143
About this study
Official title: Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study
The purpose of this study is to determine the effects of rifaximin on skin symptoms in patients with rosacea by double-blinded, placebo-controlled, crossover study.
Read the detailed description
100 patients will be randomized into two groups.
Group A will receive one rifaximin 550 mg tablet three times a day (1650 mg/day) for 14 days, and after a 4-week washout period, receive one placebo tablet three times a day for 14 days.
Group B will receive placebo first, and then rifaximin with the same dosage schedule to Group A.
Assessments will be performed before application and 4 weeks after the last dosage, for both of rifaximin and placebo.
- Conditions
- Rosacea
- Being tested
- Rifaximin (XIFAXAN), Placebo
- Keywords
- Rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin (XIFAXAN)Drug
Also called XIFAXAN
Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days
PlaceboDrug
Placebo 1 tablet three times a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days Receives: Drug: Rifaximin (XIFAXAN) |
| sugar pill | Placebo comparator | Placebo 1 tablet three times a day for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA) Score of Rosacea Symptoms
A response to treatment is defined as the achievement of an IGA score of '0 or 1' at endpoint for moderate to severe patients and achievement of an IGA score of '0' at endpoint for mild patients.
Measured: 14 days
Secondary outcomes (1)
Achieving an IGA score of 0.
Percentage of patients achieving an IGA score of '0' (cleared).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startApr 2013
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Steinhoff, MD, Ph.D., Principal investigator, UCSF, Dept. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359228
- Sponsor's protocol ID
- Salix Rifaximin Study
- Status last verified
- Apr 2014
- First submitted
- 1 Apr 2011
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT01359228
- Acronym / sponsor ID
- Salix Rifaximin Study
- Conditions
- Rosacea
- Keywords
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of rifaximin on skin symptoms in patients with rosacea by double-blinded, placebo-controlled, crossover study.
Detailed description
100 patients will be randomized into two groups.
Group A will receive one rifaximin 550 mg tablet three times a day (1650 mg/day) for 14 days, and after a 4-week washout period, receive one placebo tablet three times a day for 14 days.
Group B will receive placebo first, and then rifaximin with the same dosage schedule to Group A.
Assessments will be performed before application and 4 weeks after the last dosage, for both of rifaximin and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: Rifaximin (XIFAXAN)rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days |
| sugar pill | Placebo comparator | Drug: PlaceboPlacebo 1 tablet three times a day for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females
- > 18 years of age with rosacea defined as:
- 3-40 papules/pustules and < 2 nodules,
- A score of 2-4 on the Investigator Global Assessment
Key exclusion criteria (12 listed)
- Untreated pancreatic insufficiency
- Crohn's disease
- Ulcerative colitis
- Active celiac disease by clinical history
- End stage renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin (XIFAXAN)Also: XIFAXANRifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days | Drug | Rifaximin |
| PlaceboPlacebo 1 tablet three times a day for 14 days. | Drug | sugar pill |
Primary outcome
Investigator's Global Assessment (IGA) Score of Rosacea Symptoms
Time frame: 14 days
A response to treatment is defined as the achievement of an IGA score of '0 or 1' at endpoint for moderate to severe patients and achievement of an IGA score of '0' at endpoint for mild patients.
1 secondary outcome
Achieving an IGA score of 0.
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Steinhoff, MD, Ph.D. principal investigator
UCSF, Dept. of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifaximin (XIFAXAN) in people with Rosacea, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's Global Assessment (IGA) Score of Rosacea Symptoms (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.